Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
The goal of this clinical study is to advance the acceptance of new biomarkers designed to
detect drug-induced kidney injury in clinical trials.
The Kidney Safety Project is being conducted at four major medical centers:
- University of Southern California
- University of Minnesota
- MD Anderson Cancer Center
- Dana-Farber Cancer Institute.
Blood and urine samples will be collected from patients undergoing treatment with either
cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the
proximal tubule of the kidney. Aminoglycosides are a common antibiotic drug taken by
patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients
with head and neck cancer.
The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University
of Southern California and the University of Minnesota and aims to evaluate aminoglycoside
induced acute kidney injury in patients with cystic fibrosis.
The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at
the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate
cisplatin induced acute kidney injury in patients with head and neck cancer.
The data from the Kidney Safety Project, from both the Aminoglycoside Study and the
Cisplatin Study, will be combined for determination of the best biomarkers for predicting
drug-induced acute kidney injury.
Observational Model: Case Control, Time Perspective: Prospective
Paul Beringer, PharmD
University of Southern California
United States: Institutional Review Board
Kidney Safety - Aminoglycoside
|University of Southern California||Los Angeles, California 90033|
|University of Minnesota - Cystic Fibrosis Center||Minneapolis, Minnesota 55455|